Regulations governing human research in the US come from two main sources [1]:
- Health and Human Services (the Common Rule):
- Participating agencies [note 1] are governed by the US Department of Health and Human Services (HHS)
- Rules are published in the Code of Federal Regulations at 45 CFR 46
- The Food and Drug Administration (GCP standards):
- Rules for drugs are found in 21 CFR 312
- Rules for devices are found in 21 CFR 812
Common Rule
The Common Rule is a set of regulations for the ethical conduct of research involving human subjects, and several U.S. federal agencies participate in enforcing these regulations. These are the agencies and departments that have agreed to follow the Common Rule [2] which is codified in 45 CFR 46:
- Agency for International Development
- Department of Agriculture
- Bureau of Prisons, US Department of Justice
- Central Intelligence Agency
- Department of Commerce
- Consumer Product Safety Commission
- Department of Defense
- Department of Education
- Department of Energy
- Environmental Protection Agency
- Federal Bureau of Investigation, Department of Justice
- Department of Health and Human Services
- Department of Homeland Security
- Department of Housing and Urban Development
- Office of justice Programs, Department of Justice
- Department of Labor
- National Aeronautics and Space Administration
- National Science Foundation
- Office of the Director of National Intelligence
- Social Security Administration
- Department of Transportation
- Department of Veteran Affairs
FDA
Rules governing human research are primarily found in Title 21 of the Code of Federal Regulations (CFR).
Regulations for drugs and biologics
- 21 CFR 312 - Investigational new drug application (IND): procedures and requirements for submission
- 21 CFR 314 - New Drug Application (NDA): review the data and decide whether to approve the drug for marketing
Regulations for medical devices
- 21 CFR 812 - Investigational Device Exemptions (IDE): requirements for conducting clinical trials with medical devices
- 21 CFR 814 - Premarket Approval of Medical Devices (PMA): clinical data demonstrating the safety and effectiveness of the device
General regulations for clinical trials
- 21 CFR 11 - Electronic Records and Electronic Signatures: criteria for electronic records and signatures to be considered equivalent to paper records and handwritten signatures
- 21 CFR 50 - Protection of Human Subjects: requirements for informed consent in clinical trials
- 21 CFR 54 - Financial disclosure by clinical investigators: requirements on financial transparency and conflict of interests
- 21 CFR 56 - Institutional Review Boards (IRBs): roles and responsibilities of IRBs in reviewing and approving clinical trials
Compliance requirements
Compliance with the Common Rule:
Required when the Department of Health and Human Services (HHS) or its agencies provide funding.
Compliance with FDA rules
Required when using FDA regulated products in research.
Institutional rules
If neither the Common Rule nor FDA rules apply, the institution conducting the research will impose its own rules. These are set via institutional review board (IRB) standard operating procedures (SOPs). Institutions may also choose to apply the Common Rule to any research conducted within their facilities.
Origin of rules governing human subjects protections and IRBs
Human subjects protections and IRBs are governed by rules from the Office for Human Research Protections. These rules are published in:
- 21 CFR 50 (human subjects protections)
- 21 CFR 56 (IRBs)
See also
Another relevant pages
Links to this page
References
External links
Footnotes
- ↑ The term “Participating agencies” refers to the federal agencies that have adopted the Common Rule